Virtual RealityRAGAZNCT06604364
Virtual Reality for Reducing Anxiety in Pediatric Orthopedic Surgery
A study testing hypno VR in people with Virtual Reality, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
This study, titled "R.A.G.A.Z.: Virtual Reality for Reducing Anxiety and Pain in Pediatric Orthopedic Surgery," aims to see if using virtual reality (VR) can help children feel less anxious and experience less pain during minor orthopedic surgeries. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality
- What is being tested?
- hypno VR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 3 Jun 2024to 3 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 7 to 12 years.
- Scheduled for minor orthopedic surgery with a duration of less than 60 minutes.
- Eligible for regional anesthesia.
- Able to understand and cooperate with the study procedures.
- Consent from both the child and their parent or legal guardian.
Who cannot join
- Facial trauma that prevents the use of VR headsets.
- Blindness or significant visual impairment.
- Deafness or significant hearing impairment.
- Cognitive impairments or intellectual disabilities.
- Inability to understand the language used in the VR content.
- Poor fit of the VR headset on the child's face.
Show all 17Show fewer
- Inability to understand Italian.
- Current use of analgesics or sedatives at home.
- Certified psychiatric diagnosis.
- Epilepsy or history of seizures.
- Recent head trauma, severe headaches, or vertigo.
- Any condition deemed by the anesthesiologist to be unsafe for VR use.
- Failure to properly apply topical anesthetics before invasive procedures.
- Allergy to local anesthetics.
- Surgery duration expected to exceed 60 minutes.
- Anticipated need for general anesthesia or deep sedation requiring advanced airway management.
- Predicted difficult venous access (DIVA)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Istituto Ortopedico Rizzoli
Bologna
vittorio ferrari, 051636842 ext. 0039, 19vittorio87@gmail.com
Lesley de Pietri
About this study
Official title: realtà Aumentata Generatrice di Ansia Zero
This study, titled "R.A.G.A.Z.: Virtual Reality for Reducing Anxiety and Pain in Pediatric Orthopedic Surgery," aims to see if using virtual reality (VR) can help children feel less anxious and experience less pain during minor orthopedic surgeries. The research will compare the effects of VR to the usual pre-surgery sedative medication.
Study Hypotheses
Read more
The researchers hypothesize that using VR will:
- Reduce anxiety levels in children before and after surgery compared to standard sedative medication.
Who can participate?
- Children aged 7 to 12 years
- Undergoing minor orthopedic surgery lasting less than 60 minutes
- Eligible for regional anesthesia
Study Process
Participants will be randomly assigned to one of two groups:
- VR Group: Children will use VR headsets to immerse themselves in calming virtual environments before and during the surgery.
- Standard Care Group: Children will receive standard sedative medication before surgery.
The study will measure:
- Levels of anxiety before and after surgery using a specific anxiety meter (CAM-S).
- Stress hormone levels (cortisol, adrenaline, noradrenaline) from blood samples.
- Pain levels at different times after surgery.
- How well children cooperate during medical procedures.
- Satisfaction levels of children, parents, and surgeons.
The study is being conducted by IRCCS - Istituto Ortopedico Rizzoli in Bologna, Italy. It is a non-profit study funded by donations.
The goal is to find out if VR can reduce the need for sedatives, decrease anxiety and pain, and improve the overall surgical experience for children.
Read the detailed description
Detailed Description
This study, titled "R.A.G.A.Z.: Virtual Reality for Reducing Anxiety and Pain in Pediatric Orthopedic Surgery," aims to evaluate the effectiveness of virtual reality (VR) in reducing perioperative anxiety and pain in children undergoing minor orthopedic surgeries. The study will compare the use of VR headsets to the traditional method of pre-surgery sedation with medication.
Purpose of the Study
The primary objective of this study is to determine whether VR can provide better control of anxiety in pediatric patients before and after anesthetic and surgical procedures. The study will also assess whether VR can reduce the need for sedative and pain-relief medications, thereby minimizing potential side effects and improving recovery times.
Study Hypotheses
The researchers hypothesize that VR will:
- Significantly reduce anxiety levels in children before and after surgery compared to standard sedation practices.
- Lower stress hormone levels (cortisol, adrenaline, noradrenaline) associated with surgical procedures.
- Reduce the perceived pain during and after surgery.
- Decrease the overall consumption of sedative and analgesic medications.
- Good patient compliance during medical procedures.
- Good satisfaction levels for patients, their parents, and healthcare providers.
Study Design
This is a non-profit, randomized controlled trial conducted at the IRCCS - Istituto Ortopedico Rizzoli in Bologna, Italy. The study will include 50 children aged 7 to 12 years, who are candidates for minor orthopedic surgeries lasting less than 60 minutes. Participants will be randomly assigned to one of two groups:
- VR Group: Children in this group will use VR headsets to experience calming virtual environments such as underwater scenes or peaceful gardens. The VR sessions will begin before the surgical procedure and continue through the perioperative period.
- Standard Care Group: Children in this group will receive the usual care, which includes pre-surgery sedation with midazolam, a common sedative used to reduce anxiety.
Procedures
- Anxiety Assessment: The Children's Anxiety Meter-State (CAM-S) will be used to measure anxiety levels at multiple points: preoperatively, upon arrival at the operating room, and at 3, 6, and 24 hours postoperatively.
- Stress Hormone Levels: Blood samples will be taken at the time of venipuncture to measure cortisol, adrenaline, and noradrenaline levels, which are indicators of surgical stress.
- Pain Assessment: Pain levels will be evaluated using the Faces Pain Scale-Revised (FPS-R) at various postoperative intervals (3, 6, and 24 hours).
- Patient Compliance: The Modified Induction Compliance Checklist (MICC) will be used to assess how well children comply with medical procedures such as venipuncture and anesthesia administration.
- Satisfaction Surveys: Satisfaction levels of patients, parents, and surgeons will be recorded using a scale from 1 to 10. This will assess overall satisfaction with the VR intervention and the surgical experience.
Expected Outcomes
The study aims to demonstrate that VR can effectively reduce perioperative anxiety and pain, leading to a lower requirement for sedatives and analgesics. By providing a non-pharmacological method to manage anxiety and pain, VR could improve the overall surgical experience for pediatric patients and enhance recovery outcomes. Additionally, the study seeks to validate the feasibility and acceptability of VR as a standard practice in pediatric surgical settings.
Study Timeline
The study is expected to last 24 months, including patient enrollment, data collection, and analysis. Each participant will be involved from the preoperative visit through the first 24 hours post-surgery. The results will be analyzed and published to contribute to the growing body of evidence supporting the use of VR in medical procedures.
Ethical Considerations
The study will be conducted following the principles of the Declaration of Helsinki and Good Clinical Practice (GCP) guidelines. Informed consent will be obtained from all participants and their parents or guardians. The privacy and confidentiality of all participants will be strictly maintained.
This study has the potential to revolutionize the approach to managing perioperative anxiety and pain in pediatric patients, offering a safe, effective, and enjoyable alternative to traditional sedative medications.
- Conditions
- Virtual Reality
- Being tested
- hypno VR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypno VRDevice
pre-surgery sedation using virtual reality headset
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | pre-surgery sedation |
| VR | Experimental | virtual reality sedation Receives: Device: hypno VR |
What is being measured
The primary outcome is the main question the study is designed to answer.
anxiety level
level of anxiety with cam-s
Measured: 24 hours
Secondary outcomes (8)
hormons levels
levels of stress hormons
Measured: preoperative
pain level
difference in pain levels
Measured: 24 hours
compliance during induction
compliance during induction of anesthesia with micc
Measured: during induction
drugs dosage
dosage of drugs necessary for induction of anesthesia
Measured: intraoperative
surgeons satisfaction
general satisfaction of the surgeons from 1 to 10
Measured: immediately after the intervention
parents satisfaction
general satisfaction of the parents from 1 to 10
Measured: immediately after the intervention
or time occupation
time of occupation of the or
Measured: intraoperative
adverse event
adverse avent using virtual reality
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start3 Jun 2024
- Primary completionJun 2026 (estimated)
- Study completion3 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06604364
- Sponsor's protocol ID
- 211/2024/DISP/IOR
- Acronym
- RAGAZ
- Status last verified
- Feb 2026
- First submitted
- 10 Sep 2024
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- realtà Aumentata Generatrice di Ansia Zero
- ClinicalTrials.gov ID
- NCT06604364
- Acronym / sponsor ID
- RAGAZ / 211/2024/DISP/IOR
- Conditions
- Virtual Reality
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- 3 Jun 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study, titled "R.A.G.A.Z.: Virtual Reality for Reducing Anxiety and Pain in Pediatric Orthopedic Surgery," aims to see if using virtual reality (VR) can help children feel less anxious and experience less pain during minor orthopedic surgeries. The research will compare the effects of VR to the usual pre-surgery sedative medication.
Study Hypotheses
The researchers hypothesize that using VR will:
- Reduce anxiety levels in children before and after surgery compared to standard sedative medication.
Who can participate?
- Children aged 7 to 12 years
- Undergoing minor orthopedic surgery lasting less than 60 minutes
- Eligible for regional anesthesia
Study Process
Participants will be randomly assigned to one of two groups:
- VR Group: Children will use VR headsets to immerse themselves in calming virtual environments before and during the surgery.
- Standard Care Group: Children will receive standard sedative medication before surgery.
The study will measure:
- Levels of anxiety before and after surgery using a specific anxiety meter (CAM-S).
- Stress hormone levels (cortisol, adrenaline, noradrenaline) from blood samples.
- Pain levels at different times after surgery.
- How well children cooperate during medical procedures.
- Satisfaction levels of children, parents, and surgeons.
The study is being conducted by IRCCS - Istituto Ortopedico Rizzoli in Bologna, Italy. It is a non-profit study funded by donations.
The goal is to find out if VR can reduce the need for sedatives, decrease anxiety and pain, and improve the overall surgical experience for children.
Detailed description
Detailed Description
This study, titled "R.A.G.A.Z.: Virtual Reality for Reducing Anxiety and Pain in Pediatric Orthopedic Surgery," aims to evaluate the effectiveness of virtual reality (VR) in reducing perioperative anxiety and pain in children undergoing minor orthopedic surgeries. The study will compare the use of VR headsets to the traditional method of pre-surgery sedation with medication.
Purpose of the Study
The primary objective of this study is to determine whether VR can provide better control of anxiety in pediatric patients before and after anesthetic and surgical procedures. The study will also assess whether VR can reduce the need for sedative and pain-relief medications, thereby minimizing potential side effects and improving recovery times.
Study Hypotheses
The researchers hypothesize that VR will:
- Significantly reduce anxiety levels in children before and after surgery compared to standard sedation practices.
- Lower stress hormone levels (cortisol, adrenaline, noradrenaline) associated with surgical procedures.
- Reduce the perceived pain during and after surgery.
- Decrease the overall consumption of sedative and analgesic medications.
- Good patient compliance during medical procedures.
- Good satisfaction levels for patients, their parents, and healthcare providers.
Study Design
This is a non-profit, randomized controlled trial conducted at the IRCCS - Istituto Ortopedico Rizzoli in Bologna, Italy. The study will include 50 children aged 7 to 12 years, who are candidates for minor orthopedic surgeries lasting less than 60 minutes. Participants will be randomly assigned to one of two groups:
- VR Group: Children in this group will use VR headsets to experience calming virtual environments such as underwater scenes or peaceful gardens. The VR sessions will begin before the surgical procedure and continue through the perioperative period.
- Standard Care Group: Children in this group will receive the usual care, which includes pre-surgery sedation with midazolam, a common sedative used to reduce anxiety.
Procedures
- Anxiety Assessment: The Children's Anxiety Meter-State (CAM-S) will be used to measure anxiety levels at multiple points: preoperatively, upon arrival at the operating room, and at 3, 6, and 24 hours postoperatively.
- Stress Hormone Levels: Blood samples will be taken at the time of venipuncture to measure cortisol, adrenaline, and noradrenaline levels, which are indicators of surgical stress.
- Pain Assessment: Pain levels will be evaluated using the Faces Pain Scale-Revised (FPS-R) at various postoperative intervals (3, 6, and 24 hours).
- Patient Compliance: The Modified Induction Compliance Checklist (MICC) will be used to assess how well children comply with medical procedures such as venipuncture and anesthesia administration.
- Satisfaction Surveys: Satisfaction levels of patients, parents, and surgeons will be recorded using a scale from 1 to 10. This will assess overall satisfaction with the VR intervention and the surgical experience.
Expected Outcomes
The study aims to demonstrate that VR can effectively reduce perioperative anxiety and pain, leading to a lower requirement for sedatives and analgesics. By providing a non-pharmacological method to manage anxiety and pain, VR could improve the overall surgical experience for pediatric patients and enhance recovery outcomes. Additionally, the study seeks to validate the feasibility and acceptability of VR as a standard practice in pediatric surgical settings.
Study Timeline
The study is expected to last 24 months, including patient enrollment, data collection, and analysis. Each participant will be involved from the preoperative visit through the first 24 hours post-surgery. The results will be analyzed and published to contribute to the growing body of evidence supporting the use of VR in medical procedures.
Ethical Considerations
The study will be conducted following the principles of the Declaration of Helsinki and Good Clinical Practice (GCP) guidelines. Informed consent will be obtained from all participants and their parents or guardians. The privacy and confidentiality of all participants will be strictly maintained.
This study has the potential to revolutionize the approach to managing perioperative anxiety and pain in pediatric patients, offering a safe, effective, and enjoyable alternative to traditional sedative medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –pre-surgery sedation |
| VR | Experimental | Device: hypno VRvirtual reality sedation |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 7 to 12 years.
- Scheduled for minor orthopedic surgery with a duration of less than 60 minutes.
- Eligible for regional anesthesia.
- Able to understand and cooperate with the study procedures.
- Consent from both the child and their parent or legal guardian.
Key exclusion criteria (17 listed)
- Facial trauma that prevents the use of VR headsets.
- Blindness or significant visual impairment.
- Deafness or significant hearing impairment.
- Cognitive impairments or intellectual disabilities.
- Inability to understand the language used in the VR content.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hypno VRpre-surgery sedation using virtual reality headset | Device | VR |
Primary outcome
anxiety level
Time frame: 24 hours
level of anxiety with cam-s
8 secondary outcomes
hormons levels
Time frame: preoperative
pain level
Time frame: 24 hours
compliance during induction
Time frame: during induction
drugs dosage
Time frame: intraoperative
surgeons satisfaction
Time frame: immediately after the intervention
parents satisfaction
Time frame: immediately after the intervention
or time occupation
Time frame: intraoperative
adverse event
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hypno VR in people with Virtual Reality, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anxiety level (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.